Spinal zap trial aims to steady blood pressure in Parkinson's patients
NCT ID NCT06920134
First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times
Summary
This early study tests a spinal cord stimulation therapy called ARC-IM in 5 people with Parkinson's disease or related conditions who experience severe drops in blood pressure when standing (orthostatic hypotension). The main goal is to check safety, and researchers will also measure whether the therapy helps maintain blood pressure during a tilt-table test. The approach is not a cure but aims to control a challenging symptom.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 5 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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May 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. \> 18 years old 2. Typical or Atypical PD (including but not limited to Multiple System Atrophy, Pure Autonomic Failure, Progressive Supranuclear Palsy) 3. Confirmed orthostatic hypotension with a test for verticalization 4. Confirmed symptomatic orthostatic hypotension that makes daily activities particularly challenging as determined by the study clinicians 5. Must provide and sign the Informed Consent before any study-related procedures 6. Stable medical, physical, and psychological conditions given participant indication as considered by Investigators; 7. Able to understand and interact with the study team in French or English 8. Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments Exclusion Criteria: 1. Diseases and conditions that would increase the morbidity and mortality of the implantation surgery 2. The inability to withhold antiplatelet/anticoagulation agents perioperatively 3. History of myocardial infarction or cerebrovascular events within the past 6 months 4. Unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations as determined by the Investigator 5. History or presence of major psychiatric disorders or major neurocognitive disorders as considered by the Investigators in accordance with the treating physician and treating neurologist 6. Major changes in PD treatment planned until the end of the main study phase (such as DBS or dopamine-pump implantation) 7. Inability to follow study procedures. 8. Spinal anatomical abnormalities precluding surgery 9. Presence of any indications requiring frequent MRIs. 10. Current pregnancy or current breastfeeding 11. Lack of effective or acceptable contraception for women of childbearing capacity 12. Intention to become pregnant during the study 13. Unable or unwilling to effectively use the study system or related devices by the participant or caretaker, as determined by the investigator 14. Participation in another interventional study that might confound study endpoint evaluations 15. Enrolment of the investigator, his/her family members, employees, and other dependent persons
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHUV
RECRUITINGLausanne, Canton of Vaud, 1011, Switzerland
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